# K091516: Well Lead Silicone Catheter with Temperature Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Co., Ltd.
- Decided: Oct 16, 2009 after 147 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K896053 (1990). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873448: Foley Catheter Temperature Sensor, Respiratory Support Products, Inc. (1987) Summary page 2.
- K082815: Well Lead Silicone and Latex Foley Catheters, Well Lead Medical Instruments (2008) Summary page 2.

## Most influential descendants
- K202134: Well Lead All Silicone Foley Catheter with Temperature Sensor (2021), 0 descendants of its own

## Indications for use
The Well Lead All Silicone Foley Catheters With Temperature Sensor are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.

Source page: https://510kreport.com/device/K091516
Methodology: https://510kreport.com/methodology